Presentations will cover the regulatory framework and data required to establish the characterisation, quality, safety and efficacy of the different types of feed additives. An important part of the programme will be devoted to working on case studies in the workshop sessions, which have been designed to help consolidate learning, and there will be ample time for discussion with our expert faculty. We will also focus on the Transparency Regulation and explain the new procedure for feed additive approvals.

The format will be as interactive as possible and will be composed of a series of lectures, workshops, questionnaires, and online polls.

Key areas covered and course objectives:

• Gain a comprehensive overview of the EU regulatory framework and relevant legislation
• Understand the roles of the EU Commission, the EURL, EFSA and Member States, and learn about how the new EU Regulation on Transparency will affect the feed additive approval process
• Discuss types of feed additives and acceptable claims
• Clarify the data required – product characterisation safety, quality and efficacy
• Get to grips with EC, EURL and EFSA guidelines and guidance documents
• Learn how to conduct a strategic data audit and gap analysis
• Better manage EU registration projects
• Master the art of writing successful feed additive dossiers
• Discuss post-submission hurdles – dossier validation and EFSA clock-stops
• Know how to interact with the EU Commission, Member States and EFSA

Managers working in:

• • Regulatory affairs
  • Marketing
  • R&D
  • Product development
  • Scientists in CROs where clients demand EFSA-compliant studies
  • Those seeking to review special problems in the registration of feed additives in the EU

Joan Castelló

Joan Castelló is as a regulatory consultant for the food and animal health industry since 2018. He holds a bachelor’s degree in chemistry (Lindenwood University, USA), specialising in biochemistry. Joan gained experience in food chain safety while working as an analyst at a food microbiology testing laboratory in London, UK. Since joining Pen & Tec in 2018, Joan has been involved on the registration of feed additives in the EU as well as on the design of EFSA-compliant registration studies, and has also developed expertise in US FDA regulatory requirements.

Eliana Henríquez

Dr Eliana Henriquez Rodriguez is an Agricultural Engineer with applied experience in animal production and research. Eliana holds a MSc in Animal Breeding and Reproduction Biotechnology (Autonomous University of Barcelona and Polytechnic University of Valencia, Spain) as well as a PhD in Agricultural and Food Science and Technology (University of Lleida, Spain). Eliana’s thesis focused on the validation of genetic markers to improve pork quality and generated results published in different peer-reviewed journals. In addition to working as a supervisor on pig farms in Venezuela, Eliana’s experience in industry and academia also includes an internship with Pig Improvement Company (USA) and a laboratory research project at TEAGASC Food Research Centre (Ireland), as part of her PhD training.

Throughout her professional and academic life, Eliana has developed skills in animal production management, molecular genetic techniques, experimental design, statistical analysis and scientific writing. In her role at Pen & Tec Consulting, Eliana is responsible for providing internal & external regulatory & scientific training for EFSA- compliant studies, and manages feed additive registration projects.

Elinor McCartney

Elinor established Pen & Tec Consulting in 2000, coinciding with publication of the EU white paper on food safety, and is dedicated to providing specialist services in new product development and registration of feed additives in Europe. She has managed the growth of services to include all categories of feed additives. Elinor is a graduate of the Royal Veterinary College, where she obtained her PhD in enteric diseases of piglets. She also holds an MBA (with distinction) from the Open University and has tutored in Finance and Marketing for the Open University Business School in several European countries.

Elinor has worked in general veterinary practice, in the veterinary pharmaceutical industry and in various technical and commercial roles concerning the supply of additives and speciality ingredients to the feed industry. Elinor helps clients understand EU/EFSA legislation, guidelines and guidance and has assisted many applicants to achieve or maintain EU approval of a wide range of products, including, technological, sensory, nutritional, zootechnical and coccidiostat feed additives.

• EU Regulatory Framework – the Basic Legislation and Procedures
• EU Transparency Regulation – main changes and outline of new procedures
• EURL and EFSA Guidance Documents, EFSA Open Portal
• Workshop: Strategic Planning – Matching Commercial and Regulatory Objectives
• Notification of studies on the EFSA Open Portal
• Section II – Characterisation and Quality Requirements
• Workshop: Building Section II
• Section III – Safety for Target Animals, Consumers, Users and the Environment
• Workshop on microorganism safety & whole genome sequence requirements
• Workshop: Building Section III
• Section IV – Efficacy
• Good Study Design – Ticking the EFSA Boxes
• Workshop: Building Section IV
• Workshop Presentations
• Writing and Managing the Dossier, e-submission food chain platform
• Final Discussion, Questions and Answers

Get £200/EUR 280 early bird discount by booking before May 12.  To book the course please follow the link.